Cleared Traditional

K212448 - NightGuard Flex (FDA 510(k) Clearance)

K212448 · Sprintray, Inc. · Dental device

Nov 2021

Decision

99d

Days

Risk

K212448 is an FDA 510(k) clearance for the NightGuard Flex. This device is classified as a Mouthguard, Prescription.

Submitted by Sprintray, Inc. (Los Angeles, US). The FDA issued a Cleared decision on November 12, 2021, 99 days after receiving the submission on August 5, 2021.

This device falls under the Dental FDA review panel.

Submission Details

510(k) Number	K212448 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	August 05, 2021
Decision Date	November 12, 2021
Days to Decision	99 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Summary PDF